Effect of Probiotic and Zinc Supplementations on the Clinical Outcome in Pediatric Patients with Ventriculitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- CSF culture
研究概览
简要总结
The aim of the study is to evaluate the effect of non-antibiotic-based supplemental interventions in the management of ventriculitis among pediatric patients.
The study objective is to detect the efficacy of probiotics and zinc when taken simultaneously with antibiotic treatment as immunomodulatory in increasing the recovery rate in pediatric population affected with ventriculitis.
详细描述
Study design: A comparative, randomized, open label, controlled interventional clinical trial.
Setting:The study will be conducted at the Neurosurgery department with the Ain Shams University Hospitals.
Pediatric Patients admitted to the neurosurgery department according to the inclusion criteria will be enrolled in the study and divided into four groups using simple randomization method.
Group A: Patients administer probiotics along with the standard care of therapy for a duration of 14 days.
Lacteol fort ® Sachets manufactured by Rameda contains Lactobacillus LB corresponding to lactobacillus delbruekii and lactobacillus fermentum 10 billion units per sachet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients admitted to neurosurgery department with the diagnosis of ventriculitis will be enrolled in the study.
排除标准
- •Patients suffering from any comorbidities other than ventriculitis such as cardiovascular, autoimmune diseases. etc .
- •Patients with allergy to zinc.
- •Patients with allergy to probiotics.
研究组 & 干预措施
Probiotic group
probiotic will be administered to this group of pediatric patients with ventriculitis
干预措施: Probiotic Formula (Drug)
Zinc group
Zinc will be administered to this group of pediatric patients with ventriculitis
干预措施: Zinc (Drug)
Probiotic and Zinc group
probiotic and Zinc will be administered to this group of pediatric patients with ventriculitis
干预措施: Probiotic Formula (Drug)
Probiotic and Zinc group
probiotic and Zinc will be administered to this group of pediatric patients with ventriculitis
干预措施: Zinc (Drug)
结局指标
主要结局
CSF culture
时间窗: after 14 days of treatment
time-to-event of negative CSF culture .
normalization of the CSF chemistry
时间窗: after 14 days of treatment
including normal CSF protein and normal CSF glucose levels
safety of probiotic and zinc supplementation
时间窗: through study completion, an average of 1 year
Number of participants with treatment-related adverse events
次要结局
- length of hospital stay(through study completion, an average of 1 year)